DyslipidemiaPhase 3NCT06955104
Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia
A Phase 3 study testing JW0108 + C2407 in people with Dyslipidemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients with Dyslipidemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- JW0108 + C2407
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2025to 30 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 19 years old at the time of written informed consent
- Patients with dyslipidemia
Who cannot join
- Secondary dyslipidemia
- Patient who does not meet the specified TG, LDL-C level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients with Dyslipidemia
Read the detailed description
To evaluate the efficacy and safety of JW0108+C2407 in dyslipidemia patients
- Conditions
- Dyslipidemia
- Being tested
- JW0108 + C2407, JW0108 + C2407 placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JW0108 + C2407Drug
JW0108 + C2407
JW0108 + C2407 placeboDrug
JW0108 + C2407 placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: JW0108 + C2407 | Experimental | For 8weeks QD(Quaque Die) Receives: Drug: JW0108 + C2407 |
| Control Group: JW0108 + C2407 placebo | Active comparator | For 8weeks QD(Quaque Die) Receives: Drug: JW0108 + C2407 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in LDL-C
Check LDL-C
Measured: Week 8
Secondary outcomes (1)
Efficacy and Safety: Change from baseline in LDL-C (mg/dL)
Check LDL-C
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start3 Apr 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955104
- Sponsor's protocol ID
- JW24302
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT06955104
- Acronym / sponsor ID
- JW24302
- Conditions
- Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients with Dyslipidemia
Detailed description
To evaluate the efficacy and safety of JW0108+C2407 in dyslipidemia patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: JW0108 + C2407 | Experimental | Drug: JW0108 + C2407For 8weeks QD(Quaque Die) |
| Control Group: JW0108 + C2407 placebo | Active comparator | Drug: JW0108 + C2407 placeboFor 8weeks QD(Quaque Die) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 19 years old at the time of written informed consent
- Patients with dyslipidemia
Key exclusion criteria (2 listed)
- Secondary dyslipidemia
- Patient who does not meet the specified TG, LDL-C level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JW0108 + C2407JW0108 + C2407 | Drug | Experimental Group: JW0108 + C2407 |
| JW0108 + C2407 placeboJW0108 + C2407 placebo | Drug | Control Group: JW0108 + C2407 placebo |
Primary outcome
Percent change from baseline in LDL-C
Time frame: Week 8
Check LDL-C
1 secondary outcome
Efficacy and Safety: Change from baseline in LDL-C (mg/dL)
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JW0108 + C2407 in people with Dyslipidemia, run by JW Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in LDL-C (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.